The Effect of Family Education on Functional Level, Activity Level and Families in Children With Cerebral Palsy

February 7, 2022 updated by: Mehmet Ergun Kayiran, Hasan Kalyoncu University

The activity status of children with cerebral palsy between the ages of 3 and 18 who participated in the physiotherapy program in special education institutions throughout the province of Gaziantep was evaluated. The effect of the family education to be given on the activity status of the children and the psychosocial status of the families was investigated.

The individuals included in the study were divided into two groups as patient and control. In the beginning, the scales used to determine the activity status and the scales to determine the depression status of their families were applied in order to determine the status of both groups. Children with cerebral palsy in the patient group received treatment in a special education and rehabilitation center two days a week for 8 weeks. Individuals in the control group were followed up with a home program. After 8 weeks of treatment, the same tests were repeated and it was examined whether the family education provided made a difference in children with cerebral palsy and their parents.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Şahinbey
      • Gaziantep, Şahinbey, Turkey, 27000
        • Hasan Kalyoncu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be in the age range of 3-18 years.
  • Getting a diagnosis of cerebral palsy.
  • Agree to participate in the study.

Exclusion Criteria:

  • If the child interrupts supportive education for any reason,
  • Failure of the family to ensure continuity in participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group
Children with cerebral palsy in the patient group received treatment in a special education and rehabilitation center two days a week for 8 weeks.
Other: Physiotherapy and rehabilitation treatment in a special education and rehabilitation center.
Routine physiotherapy and rehabilitation practice was performed 2 days a week for 8 weeks in the special education and rehabilitation center.
Active Comparator: Control Group
Individuals in the control group were followed with a home program for 8 weeks.
Other: Family-based home exercise.
Home exercise was applied by the families every day of the week for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abilhand Kids (For patients)
Time Frame: Change from Baseline Abilhand Kids at 8 weeks.
It is a questionnaire consisting of 21 questions designed to test children's manual abilities. The applicability of the items by the child is evaluated in 3 steps as impossible, easy and difficult.
Change from Baseline Abilhand Kids at 8 weeks.
GMFM 66 (For patients)
Time Frame: Change from Baseline GMFM 66 at 8 weeks.
Gross motor function assessment is a computerized test consisting of 66 questions. Evaluates the sub-titles as Reaching-Rolling, Sitting, Standing and running-Jumping.
Change from Baseline GMFM 66 at 8 weeks.
PEDI (For patients)
Time Frame: Change from Baseline PEDI at 8 weeks.
It is a scale that evaluates the functional skills of the child and the help and manner of the caregiver, in which each part is evaluated separately as self-care, mobility and social function items.
Change from Baseline PEDI at 8 weeks.
Beck Depression Scale (For family)
Time Frame: Change from Baseline Beck Depression Scale at 8 weeks.
It is a survey aiming to reach the result by scoring between 0 and 3 with 21 questions. According to the total score, it is divided into 4 groups as minimal, mild, moderate and severe depression.
Change from Baseline Beck Depression Scale at 8 weeks.
IPFAM (For family)
Time Frame: Change from Baseline IPFAM at 8 weeks.
The family impact scale asks for answers in 4 categories: I strongly disagree (4 points), disagree (3 points), agree (2 points), completely agree (1 point) in 27 questions. Makes classification according to the total score.
Change from Baseline IPFAM at 8 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasan Kalyoncu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Anticipated)

April 30, 2022

Study Registration Dates

First Submitted

January 13, 2022

First Submitted That Met QC Criteria

February 7, 2022

First Posted (Actual)

February 8, 2022

Study Record Updates

Last Update Posted (Actual)

February 8, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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